CPAP mask frame

ABSTRACT

A continuous positive airway pressure (“CPAP”) mask is provided. The CPAP mask includes a mask support that includes a cavity provided within the mask support. The CPAP mask further includes a mask cushion that is received within the cavity. The mask cushion and the mask support each include an opening. Air can pass from an air delivery tube through the openings and into the mask cushion. The mask cushion can be placed around a patient&#39;s breathing orifice to deliver the air to the patient. The CPAP mask further includes a forehead support that is spaced apart form the mask support. A neck portion attaches the forehead support to the mask support. The neck portion is flexible and is molded to both the mask support and the forehead support. The flexible neck portion allows the mask support to move with respect to the forehead support.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority to U.S. provisional patent applicationNo. 61/350,958, filed on Jun. 3, 2010, the disclosure of which isexpressly incorporated herein by reference for all purposes.

FIELD

The present invention relates generally to ventilation devices, and moreparticularly, to a continuous positive airway pressure (“CPAP”) nosemask.

BACKGROUND

CPAP masks are commonly used to treat patients suffering from sleepapnea. A CPAP mask may be placed over a patient's face while sleeping todeliver air to the patient through the mask. The CPAP mask may cover apatient's nose and/or mouth during sleep to form a seal and ensureproper air flow. Straps can be used to hold the CPAP mask in place.Thus, a user can wear the CPAP mask and sleep with a steady supply ofair flow throughout the night while the mask remains secure. The size ofeach patient's face can vary, however, preventing the CPAP mask fromproperly fitting a wide range of patients. This can cause a number ofproblems, such as air leakage from the mask, pain and discomfort duringuse, decreased effectiveness, etc. Varying mask sizes (small-large,etc.) may be used, but problems still persist, such as when the strapsare tightened unevenly. Therefore, there is a continuing need for acomfortable and easily adjustable CPAP mask.

BRIEF SUMMARY

The following presents a simplified summary in order to provide a basicunderstanding of some example aspects. This summary is not an extensiveoverview. Moreover, this summary is not intended to identify criticalelements nor delineate the scope. The sole purpose of the summary is topresent some concepts in simplified form as a prelude to the moredetailed description that is presented later.

In accordance with one aspect, a continuous positive airway pressure(“CPAP”) mask is provided comprising a rigid mask support, a maskcushion coupled to the mask support, the mask cushion and the masksupport each including an opening, wherein air is configured to passthrough the opening and into the mask cushion, a rigid forehead supportspaced apart from the mask support, and a flexible neck portionintegrally molded between the forehead support and the mask frame.

In accordance with another aspect, a continuous positive airway pressure(“CPAP”) mask is provided comprising a mask support made from a firstmaterial, a forehead support made from the first material and spacedapart from the mask support, a forehead support attachment structureextending from the forehead support, the forehead support attachmentstructure including at least one attachment structure, and a neckportion made from a second material, wherein the first material and thesecond material are joined at the forehead support attachment structureby a mechanical bond.

In accordance with another aspect, a method is provided for fabricatinga continuous positive airway pressure (“CPAP”) mask, comprising thesteps of molding a mask support out of a first material, molding aforehead support out of the first material, and molding a neck portionout of a second material, wherein the neck portion is overmolded ontocorresponding portions of the mask support and the forehead support.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing and other aspects will become apparent to those skilled inthe art upon reading the following description with reference to theaccompanying drawings, in which:

FIG. 1 illustrates a perspective view of an example continuous positiveairway pressure (“CPAP”) mask;

FIG. 2 illustrates a front elevation view of an example CPAP mask frame;

FIG. 3 illustrates a side elevation view of the example CPAP mask frame;

FIG. 4 illustrates a front elevation view of the example CPAP mask frameincluding a mask support and a forehead support;

FIG. 5 illustrates a side elevation view of the example CPAP mask frameincluding the mask support and the forehead support;

FIG. 6 illustrates a rear elevation view of the example CPAP mask frameincluding the mask support and the forehead support; and

FIG. 7 illustrates a perspective view of an example neck portion of theCPAP mask frame.

DETAILED DESCRIPTION

Example embodiments that incorporate one or more aspects are describedand illustrated in the drawings. These illustrated examples are notintended to be a limitation on the present embodiments. For example, oneor more aspects of the present embodiments can be utilized in otherembodiments and even other types of devices. Moreover, certainterminology is used herein for convenience only and is not to be takenas a limitation on the present embodiments. Still further, in thedrawings, the same reference numerals are employed for designating thesame elements.

Turning to the shown example of FIG. 1, an example continuous positiveairway pressure (“CPAP”) mask 6 is shown. The CPAP mask 6 can be used tofacilitate delivery of air, such as oxygen, an oxygen mixture, gas orthe like, to a patient's nose and/or mouth. The CPAP mask 6 can includea mask cushion 8 attached to a mask frame 10. The mask cushion 8 can bedesigned to fit over the nose of a patient. An air delivery tube 9 canbe attached to the mask cushion 8 and the mask frame 10. Air can bedelivered through the air delivery tube 9. As such, air can be deliveredto the patient during sleep from the air delivery tube 9 and through themask cushion 8 to the patient's nose. Attachment structures (not shown),such as straps, bands, or the like, can be used to removably and/orflexibly attach the CPAP mask 6 to the patient's face, as will bedescribed in more detail below.

It is to be understood that varying examples of the CPAP mask 6 canincorporate some, or all, of the features described herein. Forinstance, the CPAP mask 6 may be a full face mask (not shown) as opposedto merely fitting over the nose of a patient. In such an example, theCPAP mask 6 may be large enough to cover both the nose and the mouth ofthe patient. As such, the figures and description of the CPAP mask 6described herein are not intended to limit the structure of the CPAPmask 6, and a number of different examples and variations of the CPAPmask 6 are contemplated.

Referring now to FIGS. 2 and 3, the mask frame 10 of the CPAP mask 6 isshown. The mask frame 10 can include a mask support 12. The mask support12 can define an outer boundary of the mask frame 10. As shown, the masksupport 12 includes a boundary portion that is generally triangular inshape, however other shapes are contemplated. For instance, the masksupport 12 could include a number of different shapes, including, butnot limited to circular shapes, oval shapes, rectangular shapes, or thelike. Similarly, the mask support 12 can include a variety of differentsizes, and is not limited to the size and proportion shown in theexamples. For instance, the mask support 12 can be small enough toreceive and/or fit around a patient's nose. Similarly, in anotherexample, the mask support 12 could be large enough to receive and/or fitaround both the nose and mouth of the patient, or just the mouth of thepatient. The mask support 12 can be formed from a first material. Thefirst material can include a variety of different materials, such thatthe mask support 12 can be a rigid structure. The first material caninclude, but is not limited to, a plastic material, or the like.

The mask support 12 can include one or more projecting portions 13 thatcan provide stability and/or support to the mask support 12. In theshown example, the projecting portions 13 include three projectingportions, however more or fewer projecting portions are contemplated.The projecting portions 13 can extend between an outer perimeter of themask support 12 towards a center portion 11 of the mask support 12. Theprojecting portions 13 include a rigid material that can form a backsurface of the mask support 12. The mask support 12 is not limited tothe projecting portions 13 as shown, and, in a further example, caninclude a solid, fully formed back surface instead of the projectingportions 13.

The center portion 11 of the mask support 12 can further include anopening 24. The opening 24 can be formed at an intersection of theprojecting portions 13 at a back surface of the mask support 12. Theopening 24 is shown to be substantially circular, however a number ofsizes and shapes are contemplated, such as square, rectangular, oval, orthe like. The opening 24 can be attached to the air delivery tube 9(shown in FIG. 1) at one side. The opening 24 can be sized to have adiameter that corresponds with a diameter of the air delivery tube 9.The opening 24 can form a seal, such as an air-tight seal, with the airdelivery tube 9. As such, air can pass from the air delivery tube 9 andthrough the opening 24 without escaping from the attachment between theopening 24 and the air delivery tube 9.

The mask support 12 and the projecting portions 13 can, together, definea cavity 26 formed within the mask support 12. The cavity 26 may besized to fit around a patient's nose and/or mouth, though multiple sizes(i.e., small, medium large, etc.) may be provided to accommodate varyingface sizes. The cavity 26 can be sized to receive the mask cushion 8.The opening 24 can define a path for the passage of air from an exteriorlocation, through the opening 24, and into the cavity 26.

Referring back to FIG. 1, the mask cushion 8 can be inserted andattached to the mask support 12. Specifically, the mask cushion 8 can beattached within the cavity 26. The mask cushion 8 includes an opening(not shown) that is sized to substantially match the size of the opening24. A periphery of the mask cushion 8 is configured to create a sealbetween the patient's face and the mask. The mask cushion 8 may be madeof a number of materials, such as an elastomer, rubber, or the like, andmay substantially fill the cavity 26. The mask cushion 8 can furtherprovide a delivery area for the air. The air delivery tube 9, opening24, and opening in the mask cushion 8 can each be sized to havecorresponding diameters. Both the air delivery tube 9 and mask cushion 8can be attached, such as sealingly attached, to the opening 24.Similarly, the air delivery tube 9 and the mask cushion 8 can beattached, such as sealingly attached, to each other. As such, air can bedelivered through the air delivery tube 9, through the opening 24, andinto the mask cushion 8. Air within the mask cushion 8 can pass to thepatient with minimal leakage.

The mask frame 10 can further include one or more connectors 20. Theconnectors 20 can be attached at a variety of locations within the maskframe 10, but are shown to extend from the mask support 12. Theconnectors 20 are not limited to the location of the shown example, andcan extend from a variety of locations along the mask support 12. Theshown examples include two connectors, however, it is to be understood,that more connectors or fewer connectors can be provided. Similarly, theconnectors are shown to be project outwardly as a screw shape, but cantake on a number of different structures as well. Straps, bands, or thelike, can be attached to the connectors 20. The straps can wrap around apatient's head to secure the mask frame 10 to a patient's face.

Turning now to FIGS. 4 to 6, the mask frame 10 may further include amask support attachment structure 19. The mask support attachmentstructure 19 can assist in attaching the mask support 12 to a neckportion 16. The mask support attachment structure 19 may projectoutwardly from the mask support 12 and can include a protrusion 21formed on the mask support attachment structure 19. In the shownexamples of FIGS. 3 and 4, the protrusion 21 is star-shaped, but anumber of different shapes and sizes are possible, such as a squareshape, a triangle shape, etc. As will be discussed below, the protrusion21 can assist in attaching the neck portion 16 to the mask supportattachment structure 19. The mask support attachment structure 19 can beformed from the same material as the mask support 12. In one example,the mask support 12 and mask support attachment structure 19 can includea plastic molded frame, such as a poly-carbonate, though a number ofdifferent materials are contemplated. In the alternative, the masksupport attachment structure 19 could be formed from a differentstructure.

The mask support attachment structure 19 can further include a mountingsurface 23. The mounting surface 23 can be formed at an intersection ofthe mask support attachment structure 19 and the mask support 12. Asshown in FIG. 4, the mounting surface 23 can be slightly larger indiameter than the mask support attachment structure 19, and can extendfrom a top surface to a bottom surface of the mask support attachmentstructure 19. The mounting surface 23 is shown to project at an anglewith respect to the mask support 12 and mask support attachmentstructure 19. The mounting surface 23 is not limited to the angle of theshown example, and can extend at a larger or smaller angle.

The mask frame 10 can further include a forehead support 14. Theforehead support 14 can align with a patient's forehead while the masksupport 12 and mask cushion 8 fit around a patient's nose. The foreheadsupport 14 may include a variety of geometries, such as a flat,elongated shape and/or may be curved so as to match the contours of apatient's forehead. The forehead support 14 can be formed from the firstmaterial. The first material can be similar and/or identical to thefirst material of the mask support 12. As with the mask support 12, thefirst material can include a variety of different materials, such thatthe forehead support 14 can be a rigid structure. The first material caninclude, but is not limited to, a plastic material, or the like. In analternative example, the forehead support 14 can be formed from a thirdmaterial that is different from the first material of the mask support12.

The forehead support 14 may include a cushion 17 (FIG. 1), such as apad, or the like 17 to improve comfort and adaptability of the foreheadsupport 14. The cushion 17 can be made from a flexible material such asa silicone elastomer or the like. The cushion 17 can be attached to theforehead support 14, such that the cushion 17 is positioned between theforehead support 14 and the patient's forehead. The cushion 17 mayinclude protrusions 18 allowing for the cushion 17 to be held in place,such as by a snap-fit engagement, with holes 15 in the forehead support14.

The forehead support 14 can include one or more connectors 25. Theconnectors 25 are shown to be positioned on opposing sides of theforehead support 14. The connectors 25 can be similar or identical tothe connectors 20 positioned on the mask support 12. The connectors 25can project outwardly from the forehead support 14 and can have acylindrical boss shape, but a number of other shapes and structures,such as elongated apertures, are contemplated as well. The connectors 25can project perpendicularly from the forehead support 14. For instance,the forehead support 14 can extend along a first plane while theconnectors 25 extend along a second plane that is substantiallyperpendicular to the first plane of the forehead support 14. The strapscan be attached to the connectors 25. As such, the straps can beattached to both sets of connectors 20, 25, such that the straps canwrap around the patient's head to secure the mask frame 10 to apatient's nose.

The forehead support 14 can further include a forehead supportattachment structure 28 for attaching to the neck portion 16. Theforehead support attachment structure 28 can be positioned substantiallyat a center point of the forehead support 14, however, the foreheadsupport attachment structure 28 could be offset. The forehead supportattachment structure 28 can be monolithically formed with the foreheadsupport 14, or could be separately formed and attached to the foreheadsupport 14. The forehead support attachment structure 28 can be formedfrom a plastic molded frame, such as a poly-carbonate, though a numberof different materials are contemplated.

The forehead support attachment structure 28 may include one or moreattachment structures 31, including slots, holes, openings, bores, orthe like. Specifically, the attachment structures 31 can include one ormore slots 32 positioned on the sides of the forehead support attachmentstructure 28. The attachment structures 31 can further include one ormore holes 34 extending partially or completely through the foreheadsupport attachment structure 28. The attachment structures 31 canfurther include a female bore 30 formed within the forehead supportattachment structure 28. As will be described below, the slots 32, holes34, and female bore 30 can assist in attaching the forehead supportattachment structure 28 to a neck portion 16.

The CPAP mask 6 is not limited to the attachment structures shown anddescribed herein. In further examples, the forehead support attachmentstructure 28 could include more, fewer, or alternate attachmentstructures that function similarly to the attachment structures 31 inthe shown example. For instance, the one or more slots 32 could bepositioned along a top and bottom surface of the forehead supportattachment structure 28. In another example, holes 34 may includemultiple holes, with holes positioned on side surfaces of the foreheadsupport attachment structure 28. Similarly, the forehead supportattachment structure 28 may not include a female bore 30 and, instead,may be a substantially solid structure with a filled center portion.

Referring now to FIG. 7, the neck portion 16 is illustrated. The neckportion 16 can include an elongated structure that curves at asubstantially 45° angle. It is to be understood that the neck portion 16is not limited to the angle in the shown example, and could extend atone or more other angles. The neck portion 16 can include opposing ends,including a first end 44 and a second end 45. As will be described inmore detail below, the first end 44 can be attached to the mask support12 while the second end 45 can be attached to the forehead support 14.

The neck portion 16 may be formed from a second material. The secondmaterial can include a flexible material, such as an elastomericmaterial. It is to be understood that the neck portion 16 may be formedfrom a number of materials, such as a thermoplastic elastomer (TPE) witha 40 durometer Shore A. In further examples, a variety of materials anddurometer measures are available depending on the application, includinga range of rubbers, etc. The neck portion 16 can be flexible due to thematerial, such that the neck portion 16 can be flexed, twisted, or thelike.

The second material can be overmolded onto the mask support 12 andforehead support 14. As such, the neck portion 16 can be integrallyconnected to the mask support 12 and forehead support 14. In thisexample, a single mold (not shown) may be used in the fabrication of themask frame 10. The mold may be sized and shaped to match the desireddimensions of the mask frame 10. In the first step, a rigid material,such as a polycarbonate, may be injected into the mold to form the masksupport 12 and forehead support 14. Next, after the mask support 12 andforehead support 14 have substantially solidified, the flexiblematerial, e.g., elastomer, may be injected into the mold to form theneck portion 16. The elastomer can be injected into the mold at aposition between the mask support 12 and forehead support 14. As such,the elastomer material fills in any gaps and/or surrounds the masksupport attachment structure 19 and forehead support attachmentstructure 28. The elastomer engages the attachment structures 31 byflowing into the attachment structures 31, including the female bore 30,slots 32, and/or holes 34 of the forehead support attachment structure28. The elastomer also engages the protrusion 21 and mask supportattachment structure 19 by flowing around and covering the protrusion 21and mask support attachment structure 19. The elastomer can also abutand/or contact the mounting surface 23. Accordingly, when the elastomersolidifies, the neck portion 16 is mechanically bonded directly to boththe mask support 12 and forehead support 14. Thus, the mask frame 10 isformed of one integrally connected piece, including the mask support 12connected to the forehead support 14 by the elastomeric neck portion 16.

In addition to the mechanical bond formed between the neck portion 16,mask support 12 and forehead support 14, a chemical bond may also beformed. During the overmolding process, a bond can be formed due tomelting and/or chemical adhesion of the surfaces of the neck portion 16to both the mask support attachment structure 19 and forehead supportattachment structure 28. In such an example, melting and/or a chemicalreaction may occur between the surfaces to form the bond. The strengthof the bond may vary due to a number of factors, including the types ofmaterial used, melting points of the materials, etc. Upon solidifying,the chemical bond is formed, thus ensuring that the mask frame 10 isintegrally connected as one piece.

In an alternate method of manufacture, the neck portion 16 can be formedseparately from the mask support 12 and forehead support 14.Accordingly, the neck portion 16 can be formed such that the first end44 can be attached to the mask support 12 and the second end 45 can beattached to the forehead support 14. For instance, the neck portion 16may include one or more projections 36 at the second end 45 forinsertion into the slots 32 of the forehead support attachment structure28. Though not shown in the drawings, the neck portion 16 may furtherinclude a circular projection for insertion into the one or more holes34. At an opposite end, the first end 44 of the neck portion 16 mayinclude a star-shaped female receiving portion (not shown) for engagingwith the protrusion 21. The first end 44 may also include an angledsurface 37 for engaging with the mounting surface 23. The angled surface37 can be sized and shaped to substantially match the angle of themounting surface 23, such that the angled surface 37 and the mountingsurface 23 are in close engagement with each other.

Once formed, the neck portion 16 is substantially s-shaped and can allowfor the forehead support 14 to have some movement independent of themask support 12. For instance, if the attachment structures (not shown)attached to the connectors 20, 25 are unevenly tightened, the neckportion 16 can provide for side to side torsion, thereby ensuring thatthe mask support 12 fits snugly over the patient's nose. Similarly, themask support 12 and forehead support 14 can be moved along multiple axeswhile still maintaining the necessary control to provide resistance tothe mask frame 10 and ensure seal integrity and proper internalpressure.

The invention has been described with reference to the exampleembodiments described above. Modifications and alterations will occur toothers upon a reading and understanding of this specification. Examplesembodiments incorporating one or more aspects of the invention areintended to include all such modifications and alterations.

What is claimed is:
 1. A method for fabricating a continuous positiveairway pressure (“CPAP”) mask, comprising the steps of: molding a masksupport out of a first material; molding a forehead support out of thefirst material, the mask support and the forehead support being separateand spaced apart; and molding a neck portion out of a second material,wherein the neck portion is overmolded onto corresponding portions ofthe mask support and the forehead support to connect the mask support tothe forehead support.
 2. The method of claim 1, further including themethod step of providing the forehead support with at least oneattachment structure.
 3. The method of claim 2, wherein the secondmaterial includes an elastomeric material, further wherein theelastomeric material flows around the at least one attachment structure.4. The method of claim 1, further including the method step of forming achemical bond between the neck portion and the mask support and forminga chemical bond between the neck portion and the forehead support.
 5. Amethod for fabricating a continuous positive airway pressure (“CPAP”)mask, comprising the steps of: molding a mask support out of a firstmaterial; molding a forehead support out of the first material; andmolding a neck portion out of a second material, wherein the neckportion is overmolded onto corresponding portions of the mask supportand the forehead support, wherein the neck portion molded out of thesecond material is a sole connection between the mask support and theforehead support.
 6. The method of claim 5, further including the methodstep of providing the forehead support with at least one attachmentstructure.
 7. The method of claim 6, wherein the second materialincludes an elastomeric material, further wherein the elastomericmaterial flows around the at least one attachment structure.
 8. Themethod of claim 5, further including the method step of forming achemical bond between the neck portion and the mask support and forminga chemical bond between the neck portion and the forehead support.